510(k) · Cleared

Cleared

Auravue Pit & Fissure Sealant

K070693510(k) TraditionalCleared May 9, 200757-day reviewClass II21 CFR 872.3690

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Denali Corporation · EBF Material, Tooth Shade, Resin

Cleared on May 9, 2007 after a 57-day review. The FDA summary names its predicate without a number.

Decided: May 9, 2007
Review: 57 days
Class: Class II
Product code: EBF
Recalls: None
Predicates: 0

The FDA summary names its predicate without a number.

FIG. 1 — Lineage of K070693Source: FDA 510(k) database · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in EBF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new EBF device

#1 K202846 Tera Harzscore 18.5 · 7 generations · no Class I recall
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What was it cleared against? (3)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Recalls
*	—	CosineSeal Pit and Fissure Sealant Named without a submission number	—
*	—	UltraSeal XT Pit and Fissure Sealant and Flowable Composite Kit Named without a submission number	—
*	—	Delton Clear Pit and Fissure Sealant Kit Named without a submission number	—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

How does its category compare?

All EBF devices

EBF Material, Tooth Shade, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · EBF

15in 2025

2007high 20 (2009) · low 9 (2023)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EBF

43in 2025

2007high 205 (2016) · low 43 (2025)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · EBF

1in 2020

2007high 42 (2008) · low 0 (2012)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · EBF

1in 2025

2007high 246 (2013) · low 1 (2025)2025

MAUDE reports naming product code EBF, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	19	49	1	6
2008	14	79	42	10
2009	20	84	1	8
2010	19	75	6	31
2011	19	81	7	31
2012	11	86	0	62
2013	13	153	0	246
2014	10	112	0	195
2015	17	123	0	119
2016	20	205	0	143
2017	15	108	4	42
2018	15	115	0	8
2019	17	159	2	11
2020	15	190	1	2
2021	13	178	0	2
2022	17	63	0	2
2023	9	87	0	8
2024	18	120	0	5
2025	15	43	0	1
2026	16	59	2	—

What is it indicated for?

AuraVue is a clear pit and fissure sealant. Because this material is clear this allows observation of the tooth surface. AuraVue is color stable which allows the material to be indicative of conditions which may occur beneath the sealant. This would include possible leakage, staining and also allows the use of caries detecting devices. AuraVue has excellent sealing ability and has demonstrated clinical success as a sealant. AuraVue is recommended for pit and fissure application and for minimally invasive dentistry. AuraVue is also recommended for sealing of composite enamel margins and as a composite sealer. AuraVue is available in both fluoride and non-fluoride releasing formulas.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K070693 · printed Nov 3, 2026

Cite this page

510(k) Report. “K070693: Auravue Pit & Fissure Sealant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K070693

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Page last updated Nov 3, 2026